AGM Presentation 2013 CALZADA LIMITED ASX:CZD November 2013 - - PowerPoint PPT Presentation

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AGM Presentation 2013 CALZADA LIMITED ASX:CZD November 2013 - - PowerPoint PPT Presentation

For personal use only AGM Presentation 2013 CALZADA LIMITED ASX:CZD November 2013 Disclaimer For personal use only Disclaimer This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No


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CALZADA LIMITED

ASX:CZD November 2013

AGM Presentation 2013

For personal use only

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Disclaimer

Disclaimer

This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No party other than Calzada has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or undertakings in this presentation. This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment

  • bjectives, financial situation or needs of any particular investor. Calzada Limited makes no warranty or representation (express or implied) as

to the accuracy, reliability or completeness of the information contained in this presentation. Specifically, several matters referred to in the presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation. Further, any opinions (including any forward looking statements) expressed in this presentation are subject to change without notice. Calzada and its directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent misstatement) for any statements, opinions, information or matters (express or implied) arising out of, or contained in or derived from, or for any

  • missions from this presentation, except liability under statute that cannot be excluded.

This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect

  • f shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other

jurisdiction in which, or to any person to whom, such an offer would be illegal.

Forward-looking statements

This presentation may include forward-looking statements. Forward-looking statements are only predictions and are subject to known and unknown risks, uncertainties and assumptions, many of which are outside the control of Calzada. Actual values, results or events may be materially different to those expressed or implied in this presentation depending on a range of factors. Given these uncertainties, recipients are cautioned not to place reliance on forward-looking statements. No representation or warranty (express or implied) is made by Calzada or any of its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this presentation will be achieved.

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Calzada Limited

Directors

David Franklyn Chairman Bruce Rathie Non Exec. David McQuillan Non Exec.

Calzada LTD

ASX Code CZD Share Price 7.3 cents Issued Shares 416m Market Cap. $30 million Cash on Hand* $6.2 million

Major Shareholders

Merchant Funds 16% Management 8% Monash / Frank Ng 4%

*Includes estimated R&D tax concession

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2013 Key Achievements

  • NovoSorbTM Topical Negative Pressure (TNP) wound dressing (NovoPoreTM)

successfully completed 20 patient clinical trial

  • Submitted 510(k) for US marketing of NovoPoreTM wound dressing
  • Biodegradable Temporising Matrix (BTM) polymer burn and wound scaffold

successfully completed 10 patient clinical trial in deep surgical wounds repairing dermal tissue & enabling skin graft

  • Received HREC approval for 5 patient burns trial
  • New projects initiated using NovoSorbTM polymer technology
  • Hernia repair and facial aesthetic implants

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The NovoSorb™ Technology

Foam Polymers Other Polymers

Facial Augment.

NovoSorbTM

TNP Wound Dressings Dermal Replacement Pelvic Floor Repair Hernia Repair Orthopaedic implants Cardio- vascular Stents Bone Void Fillers Drug eluting coatings

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New patents/strengthening IP protection

Title Country Application/ Registration No. Biocompatible and biodegradable (di)isocyanate and polyols USA 8,529,880 Biocompatible and biodegradable (di)isocyanate and polyols USA 8,343,472 Biocompatible polymer compositions USA 8,445,581 Biocompatible polymer compositions China ZL 200780033287.6 High modulus polyurethane and polyurethane/urea compositions Australia 2008307139 High modulus polyurethane and polyurethane/urea compositions USA 8,357,767 High modulus polyurethane and polyurethane/urea compositions China 200880117872.9 FDM Process India 254392 FDM Process Malaysia MY-146259-A FDM Process China 200580014001.0 Chain extenders Australia 2006294414 Chain extenders China 200680039476.X Chain extenders Japan 2008-531485

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Current Regulatory Activities

Europe

  • Contract Notified Body (TUV SUD, Munich) to achieve marketing

authorisation in Europe for medical devices using NovoSorbTM

  • Contract Clinical Research Organisation (MedPass, Paris)
  • To obtain ethics approval for a burns clinical trial
  • To provide regulatory strategy for medical device marketing in

Europe

  • ISO 13485 accreditation for device manufacturing
  • NovoPoreTM TNP dressing CE Mark application

United States

  • 510(k) tissue scaffold for surgical wounds submission
  • Preparation of FDA Material Master File for NovoSorbTM
  • PMA for BTM in 3rd degree burns (pending BARDA contract)

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Leveraging the Technology

What we have

  • NovoSorbTM BTM the world’s first entirely synthetic

dermal replacement matrix

  • Advantages over existing animal collagen

based products

  • NovoPoreTM TNP dressing
  • First regulatory submission for a NovoSorbTM

product

  • Safe and adaptable polymer technology
  • De-risked through 10 yrs development

culminating in successful clinical trials

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Goals for the next 12 months

  • Obtain regulatory approvals for TNP and BTM
  • BTM burns trial in Australia commencing recruitment by year end

(2013)

  • European key opinion leader to conduct BTM burns trial in Europe H1

2014

  • Continue to build IP position
  • Leverage data/approvals for further NovoSorbTM applications
  • Investigate non-dilutive funding (eg. Grants) for further development

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2013 Key Achievements

  • Key patent filed - Use of AOD9604 to treat conditions related to muscle &

cartilage and a range of other indications

  • Released positive rabbit model data showing efficacy in treating

Osteoarthritis with AOD9604

  • Progressed achieving unconditional GRAS status to allow AOD9604 to be

sold as a food/drink additive or dietary supplement in the US. Publication of required animal trial safety data is nearing completion

  • Identified the opportunity to derive near term royalties from prescription

sales of AOD9604 by compounding pharmacies

  • Low cost strategy to realise shareholder value

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AOD9604 Background

Growth Hormone activates both the IGF-1 (crossed out) and direct cellular

  • pathways. AOD9604 does not act on the IGF-1 pathway which causes

significant insulin resistance and other negative side-effects.

2nd hormone - IGF1 (made in the liver)

Fat

AOD9604

Growth hormone fragment

(only 8% of the GH molecule)

Bone

Muscle and Organ growth Bone length Protein synthesis

Burns fat, Inhibits storage IGF-1 and pro-diabetic effects removed

Cartilage & Muscle

Promotes repair IGF-1 pathway Direct cellular pathway

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AOD9604 in Osteoarthritis in vivo

  • Rabbit collagenase model of knee osteoarthritis (Kim et al 2010)
  • Positive results released on 5 February 2013
  • AOD given as a single intra-articular injection had similar efficacy to Hyaluronic acid (HA) on

cartilage repair and recovery from lameness

  • AOD combined with HA was significantly more effective than each given alone

G1 Saline control G2 HA treated G3 AOD treated G4 AOD plus HA

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Case for AOD9604 in Osteoarthritis

  • Benign safety and tolerability profile based on animal studies and previous

trials in 925 human subjects

  • Novel mechanism of action protected by patent, filed Dec 2012
  • Bone, cartilage and muscle repair with positive effects on mesenchymal stem

cells

  • Early recovery from lameness suggests pain relief effect
  • Pain may be an early efficacy surrogate in clinical trials
  • Safe & effective by Intra-articular injection. May combine with HA
  • Possible beneficial side-effect profile advantageous in OA patients
  • Positive early-stage profile for Osteoarthritis treatment in human and

veterinary subjects

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Licensing to Compounding Pharmacies

  • Anecdotal evidence indicates that AOD9604 is being prescribed to reduce

body fat and for muscle & cartilage repair

  • Registered doctors can legally prescribe AOD9604
  • Prescriptions can be legally made up by compounding pharmacies under Item

6, Schedule 5 to the Therapeutic Goods Regulations (extemporaneous compounding)

  • Legal opinion confirms Metabolic can licence AOD9604 to compounding

pharmacies for filling prescriptions

  • Increasing number of doctors are investigating AOD9604 and prescribing to

their patients

  • Potential near term revenue to Metabolic

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Immediate Future Goals

  • License AOD9604 to compounding pharmacies
  • Progress discussions with potential licensees
  • Explore human and veterinary medicine partnering opportunities
  • Potential human applications for the treatment of bone, muscle & cartilage

disorders

  • Veterinary applications – osteoarthritis, obesity and others
  • Currently in early stage discussions with several parties
  • License AOD9604 for GRAS & other Over-the-Counter
  • pportunities
  • Commercial options being investigated
  • One party conducting due diligence

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